title: Phytosterols, red yeast rice, and lifestyle changes instead of statins: a randomized, double-blinded, placebo-controlled trial.
abstract: BACKGROUND
  Many patients who refuse or cannot tolerate statin drugs choose alternative therapies for lipid lowering.
  
  
  OBJECTIVE
  This study aimed to determine the lipid-lowering effects of phytosterol tablets and lifestyle change (LC) on top of red yeast rice (RYR) therapy in patients with a history of statin refusal or statin-associated myalgias.
  
  
  METHODS
  A total of 187 participants (mean low-density lipoprotein cholesterol [LDL-C], 154 mg/dL) took RYR 1800 mg twice daily and were randomized to phytosterol tablets 900 mg twice daily or placebo. Participants were also randomized to a 12-week LC program or usual care (UC). Primary end point was change in LDL-C at 12, 24, and 52 weeks. Secondary end points were effect on other lipoproteins, high-sensitivity C-reactive protein, weight, and development of myalgia.
  
  
  RESULTS
  Phytosterols did not significantly improve LDL-C at weeks 12 (P = .54), 24 (P = .67), or 52 (P = .76) compared with placebo. Compared with the UC group, the LC group had greater reductions in LDL-C at weeks 12 (-51 vs -42 mg/dL, P = .006) and 24 (-48 vs -40 mg/dL, P = .034) and was 2.3 times more likely to achieve an LDL-C <100 mg/dL (P = .004). The LC group lost more weight for 1 year (-2.3 vs -0.3 kg, P < .001). All participants took RYR and had significant decreases in LDL-C, total cholesterol, triglycerides, high-sensitivity C-reactive protein, and an increase in high-density lipoprotein cholesterol for 1 year when compared with baseline (P < .001). Four participants stopped supplements because of myalgia.
  
  
  CONCLUSIONS
  The addition of phytosterol tablets to RYR did not result in further lowering of LDL-C levels. Participants in an LC program lost significantly more weight and were more likely to achieve an LDL-C <100 mg/dL compared with UC.
authors.affiliation: Division of Cardiology, Chestnut Hill Hospital, Philadelphia, PA, USA. dbeckerchcardiology@hotmail.com
authors.forename: David J
authors.initials: DJ
authors.lastname: Becker
authors.forename: Benjamin
authors.initials: B
authors.lastname: French
authors.forename: Patti B
authors.initials: PB
authors.lastname: Morris
authors.forename: Erin
authors.initials: E
authors.lastname: Silvent
authors.forename: Ram Y
authors.initials: RY
authors.lastname: Gordon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001688:Biological Products / Q000627:therapeutic use*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D008019:Life Style; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001688:Biological Products; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D010840:Phytosterols; C117343:red yeast rice